Last updated on August 2016

Scaphoid Non-union and Low-intensity Pulsed Ultrasound


Brief description of study

This is a prospective, double-blind, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid non-unions after operative fixation as measured by serial CT scanning. Multiple centers within the Calgary zone will be involved in the study in order to recruit enough patients to power the study. Blinding will include patients, surgeons, research assistants, as well as all data handlers and analysts until trial completion or mid-term analysis.

Detailed Study Description

This is a prospective, double-blind, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid non-unions after operative fixation as measured by serial CT scanning. Multiple centers within the Calgary zone will be involved in the study in order to recruit enough patients to power the study. Blinding will include patients, surgeons, research assistants, as well as all data handlers and analysts until trial completion or mid-term analysis. Baseline demographics including age, hand dominance, work status and medical co-morbidities of the patients will be collected to allow for comparison of the groups to ensure similarity. Patients will be identified during clinic appointment for the initial consultation for surgical fixation of their scaphoid non-union. Patients consenting to surgical fixation will be assessed for inclusion and exclusion criteria and, if appropriate, will be consented and evaluated for baseline range of motion, grip strength, SF-36, DASH and both resting and activity VAS scores. Pre-operative radiographs will be assessed for the degree of wrist arthritis present. No restrictions will be placed on the selection or scheduling of surgical procedures, but the use of other adjuvants such as bone morphogenic protein will be limited. Bioventus will provide visually identical active and sham Exogen 4000 units. The units will undergo randomization and will be given consecutively numbered labels. Devices will be securely stored at each clinical study center. All clinical centers and personnel involved will be blinded to the randomization. Two weeks post-operatively subjects will attend cast clinic and be assigned the next sequential device. The device will be applied through a window cut into the standardized cast with a center point over the anatomic snuffbox. This cast will remain in place until the fracture is united on CT, or 7 weeks at a minimum. Treatment will be self-administered for 20 minutes once daily by the patients. The device will be equipped with a system to document compliance with the treatment. Treatment will continue until the subject has greater than 50% cortical bridging on CT scanning with multi-planar reconstruction. Union will be confirmed by both an orthopedic surgeon and by an independent musculoskeletal radiologist. Treatment will also be terminated if the subject continues to have non-union present at 6 months post-operatively. Subjects will be assessed for union using serial CT scans until union is documented. CT scans will take place at 7-9 weeks, 12-14 weeks and then every 4-6 weeks thereafter as per current clinical standards of practice. Standard scaphoid and wrist radiographs will be completed within 1 week of the CT scan. Patients who do not have documented union will be classified as persistent non-unions but will be asked continue to attend clinical follow ups until 1 year. Patients will be required to attend baseline follow up at 8, 12, 16, 36 and 52 weeks for functional assessments. Patients requiring additional surgery such as bone grafting as deemed necessary by their treating surgeon will be scheduled at the surgeon's discretion and the surgery will be recorded as a trial adverse event.

Clinical Study Identifier: NCT02383160

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Alexandra Garven

Peter Lougheed Centre
Calgary, AB Canada
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Neil White, MD

South Health Campus
Calgary, AB Canada
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